BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER US DESC-CEMENT BIOMET BC R 1X40

    MDR report key: 22576620 · Received July 23, 2025

    Report

    Report Number
    MW5173115
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    June 12, 2025
    Report Date
    July 18, 2025
    Manufacturer
    BIOMET FRANCE
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2022. AFTER ABOUT ONE YEAR, PATIENT DEVELOPED PERSISTENT PROGRESSIVE PAIN IN HER LEFT KNEE. IT WAS DECIDED TO BRING PATIENT BACK FOR A REVISION LEFT TOTAL KNEE ARTHROPLASTY. DURING CASE IT WAS DISCOVERED THAT THERE WAS ASEPTIC LOOSENING OF THE ORIGINAL IMPLANTS. THE PRIMARY IMPLANTS AND BONE CEMENT WERE REMOVED WITHOUT DIFFICULTY AND THAT THE BONE CEMENT INTERFACE HAD FAILED. THE PATIENT HAD VERY LITTLE BONE LOSS WITH PRIMARY IMPLANT AND CEMENT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590987 ZIMMER US DESC-CEMENT BIOMET BC R 1X40 BONE CEMENT LOD BIOMET FRANCE I1603Y37CA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention